BioPharma Dive April 30, 2024
The new policy aims to ensure important diagnostics remain available to patients, but some experts caution the increased regulatory burdens could slow access to testing.
Federal officials said a new rule expanding regulatory oversight of laboratory-developed tests will protect patients from inaccurate results while maintaining access to important diagnostics.
But some industry experts disagree, arguing the new requirements could limit the availability of tests. Others predict the rule may face legal challenges.
On Monday, the Food and Drug Administration released its contentious final rule placing laboratory-developed tests, or LDTs, under the same regulatory framework as medical devices and other in vitro diagnostics used across multiple hospitals and labs. A growing category, LDTs are manufactured and used within a single lab.
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